MyopiaNCT06577948
The P.A.U.S.E.® Spectacle Study
A study testing Single vision spectacle lens, P.A.U.S.E. spectacle lens 1 and P.A.U.S.E. spectacle lens 2 in people with Myopia and Myopia Progression, run by nthalmic Pty Ltd at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Myopia, Myopia Progression
- What is being tested?
- Single vision spectacle lens, P.A.U.S.E. spectacle lens 1 and P.A.U.S.E. spectacle lens 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Sep 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between 6-14 years inclusive at time of enrolment.
- Have:
- Read the Informed Assent.
- Been explained the Informed Assent.
- Indicated an understanding of the Informed Assent.
- Signed the Informed Assent.
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- Have their parent / legal guardian:
- Read the Informed Consent.
- Been explained the Informed Consent.
- Indicated an understanding of the Informed Consent.
- Signed the Informed Consent.
- Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
- Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
- Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.
- Be in good general health, based on the parent's / legal guardian's knowledge.
- Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.8) or better in each eye.
- Meet the following criteria determined by cycloplegic autorefraction at Baseline:
- o-5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS. o-1.50 DC ≤ astigmatic component ≤ 0 DC. o|Spherical equivalent anisometropia| ≤ 1.00 D.
Who cannot join
- Participant is currently an active participant in another study or was active participant in another study within 30 days prior to this study.
- Current or prior use of interventions intended for myopia control, including but not limited to:
- Optical devices:
- Bifocal / multifocal spectacles.
- Bifocal / multifocal contact lenses.
- Orthokeratology.
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- Pharmacological agents:
- Atropine with a concentration > 0.01%.
- Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
- Pirenzepine.
- Participant born earlier than 30 weeks or weighed < 1500 g at birth.
- o A verbal report from the participant's parent / legal guardian is sufficient.
- Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
- A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
- Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
- Known ocular or systemic disease, such as but not limited to:
- Diabetes.
- Graves' disease.
- Glaucoma.
- Uveitis.
- Scleritis.
- Auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogren's syndrome, and systemic lupus erythematosus.
- Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
- Persistent pupillary membrane.
- Vitreous haemorrhage.
- Cataract.
- Central corneal scarring.
- Eyelid haemangiomas.
- Marfan's syndrome.
- Down's syndrome.
- Ehler's-Danlos syndrome.
- Stickler's syndrome.
- Ocular albinism.
- Retinopathy of prematurity.
- Keratoconus or irregular cornea.
- The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectacle Lenses Utilising P.A.U.S.E.® Technology for Slowing Down Myopia Progression in Vietnamese Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial
The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares P.A.U.S.E.® spectacle lenses to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing P.A.U.S.E.® spectacle lenses. The main questions to answer are:
Do P.A.U.S.E.® spectacle lenses slow down the rate of axial length growth? Do P.A.U.S.E.® spectacle lenses slow down the rate of increase in myopic refractive error?
Read more
Researchers will compare P.A.U.S.E.® spectacle lenses to a single vision spectacle lens for 12 months followed by assessing P.A.U.S.E.® spectacle lenses for slowing down myopia progression for another 12 months.
Participants will be initially randomly allocated to wear either P.A.U.S.E.® spectacle lenses or single vision spectacle lenses and visit the clinic on five occasions over the first 12 months period.
After completing the first 12 months, all participants will wear P.A.U.S.E.® spectacle lenses and visit the clinic on three occasions over the second 12 months period.
Read the detailed description
The aims of this clinical trial are:
- To compare the rate of myopia progression as measured by change from the Stage 1 Dispensing visit (up to 40 days from Baseline), in axial length and the change from Baseline in the cycloplegic spherical equivalent autorefraction between two spectacle lens designs using P.A.U.S.E.® technology (test-1 and test-2) and single vision spectacle lenses (control). Myopic children (6-14 years of age) will be randomly allocated to wear either test-1, test-2, or control.
- To assess the rate of myopia progression as measured by change from the Stage 2 Dispensing visit (up to 40 days from the Stage 1: 12-months visit), in axial length and the change from the Stage 1: 12-months visit in the cycloplegic spherical equivalent autorefraction while wearing P.A.U.S.E.® spectacle lenses. The myopic children from Stage 1 will enter Stage 2.
The overall trial duration, including follow-up period, is expected to be approximately 30 months. Each participant's duration is expected to be approximately 24 months.
The visits are:
Stage 1: Baseline, Dispensing, 1-, 6-, 12-months. Stage 2: Dispensing, 6- and 12- months
All procedures performed at these visits are standard, non-invasive clinical tests.
- Conditions
- Myopia, Myopia Progression
- Being tested
- Single vision spectacle lens, P.A.U.S.E. spectacle lens 1, P.A.U.S.E. spectacle lens 2
- Keywords
- axial length, cycloplegic spherical equivalent autorefraction
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single vision spectacle lensDevice
Standard single vision spectacle lens
P.A.U.S.E. spectacle lens 1Device
P.A.U.S.E. spectacle lens 1
P.A.U.S.E. spectacle lens 2Device
P.A.U.S.E. spectacle lens 2
| Study group | Role | What they receive |
|---|---|---|
| Assigned Intervention 1 | Active comparator | Single vision spectacle lens Receives: Device: Single vision spectacle lens |
| Assigned Intervention 2 | Experimental | P.A.U.S.E. spectacle lens 1 Receives: Device: P.A.U.S.E. spectacle lens 1 |
| Assigned Intervention 3 | Experimental | P.A.U.S.E. spectacle lens 2 Receives: Device: P.A.U.S.E. spectacle lens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length
Difference in change from Stage 1 dispensing in axial length between each test and control. The change in axial length from the Stage 2 dispensing.
Measured: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Stage 1: Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months), then 6- and 12-months after Stage 2: Dispensing Visit.
Secondary outcomes (3)
Cycloplegic spherical equivalent autorefraction
Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control.
The change in cycloplegic spherical equivalent autorefraction from the Stage 2: 12 months visit.
Measured: Stage 1: Baseline, then 6- and 12-months after Stage 1: Dispensing Visit (up to 40 days from Baseline). Stage 2: Stage 1: 12 months visit, then 6- and 12-months after after Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months visit).
Visual performance as measured by high contrast visual acuity at 6 m
Difference in high contrast visual acuity at 6 m between each test and control. High contrast visual acuity at 6 m while wearing P.A.U.S.E.® spectacle lenses.
Measured: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Dispensing Visit Stage 2: Dispensing Visit (up to 40 days from Stage 2: 12 month), then 6- and 12-months after Dispensing Visit
Visual performance as measured by a non validated questionnaire based on a 1-10
Difference in subjective visual performance between each test and control. Subjective visual performance while wearing P.A.U.S.E.® spectacle lenses.
Measured: Stage 1: 1-, 6-, and 12-months after Dispensing Visit (up to 40 days from Baseline). Stage 2: 6- and 12-months after Dispensing Visit (up to 40 days from Stage 1: 12-months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start14 Sep 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- nthalmic Pty Ltd
- Sponsor type
- Research network
- Collaborators
- Brighten Optix Corporation
- Responsible party
- Principal investigator, Daniel Tilia, MOptom, PhD, nthalmic Pty Ltd
- Investigators
- Daniel Tilia, MOptom, PhD, Principal investigator, nthalmic Pty Lyd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577948
- Sponsor's protocol ID
- nthal2024-01
- Status last verified
- May 2026
- First submitted
- 27 Aug 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectacle Lenses Utilising P.A.U.S.E.® Technology for Slowing Down Myopia Progression in Vietnamese Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial
- ClinicalTrials.gov ID
- NCT06577948
- Acronym / sponsor ID
- nthal2024-01
- Conditions
- Myopia, Myopia Progression
- Keywords
- axial length, cycloplegic spherical equivalent autorefraction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 205 participants (actual)
- Lead sponsor
- nthalmic Pty LtdResearch network
- Collaborators
- Brighten Optix Corporation
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares P.A.U.S.E.® spectacle lenses to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing P.A.U.S.E.® spectacle lenses. The main questions to answer are:
Do P.A.U.S.E.® spectacle lenses slow down the rate of axial length growth? Do P.A.U.S.E.® spectacle lenses slow down the rate of increase in myopic refractive error?
Researchers will compare P.A.U.S.E.® spectacle lenses to a single vision spectacle lens for 12 months followed by assessing P.A.U.S.E.® spectacle lenses for slowing down myopia progression for another 12 months.
Participants will be initially randomly allocated to wear either P.A.U.S.E.® spectacle lenses or single vision spectacle lenses and visit the clinic on five occasions over the first 12 months period.
After completing the first 12 months, all participants will wear P.A.U.S.E.® spectacle lenses and visit the clinic on three occasions over the second 12 months period.
Detailed description
The aims of this clinical trial are:
- To compare the rate of myopia progression as measured by change from the Stage 1 Dispensing visit (up to 40 days from Baseline), in axial length and the change from Baseline in the cycloplegic spherical equivalent autorefraction between two spectacle lens designs using P.A.U.S.E.® technology (test-1 and test-2) and single vision spectacle lenses (control). Myopic children (6-14 years of age) will be randomly allocated to wear either test-1, test-2, or control.
- To assess the rate of myopia progression as measured by change from the Stage 2 Dispensing visit (up to 40 days from the Stage 1: 12-months visit), in axial length and the change from the Stage 1: 12-months visit in the cycloplegic spherical equivalent autorefraction while wearing P.A.U.S.E.® spectacle lenses. The myopic children from Stage 1 will enter Stage 2.
The overall trial duration, including follow-up period, is expected to be approximately 30 months. Each participant's duration is expected to be approximately 24 months.
The visits are:
Stage 1: Baseline, Dispensing, 1-, 6-, 12-months. Stage 2: Dispensing, 6- and 12- months
All procedures performed at these visits are standard, non-invasive clinical tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Assigned Intervention 1 | Active comparator | Device: Single vision spectacle lensSingle vision spectacle lens |
| Assigned Intervention 2 | Experimental | Device: P.A.U.S.E. spectacle lens 1P.A.U.S.E. spectacle lens 1 |
| Assigned Intervention 3 | Experimental | Device: P.A.U.S.E. spectacle lens 2P.A.U.S.E. spectacle lens 2 |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Be between 6-14 years inclusive at time of enrolment.
- Have:
- Have their parent / legal guardian:
- Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
- Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
Key exclusion criteria (36 listed)
- Participant is currently an active participant in another study or was active participant in another study within 30 days prior to this study.
- Current or prior use of interventions intended for myopia control, including but not limited to:
- Participant born earlier than 30 weeks or weighed < 1500 g at birth.
- o A verbal report from the participant's parent / legal guardian is sufficient.
- Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single vision spectacle lensStandard single vision spectacle lens | Device | Assigned Intervention 1 |
| P.A.U.S.E. spectacle lens 1P.A.U.S.E. spectacle lens 1 | Device | Assigned Intervention 2 |
| P.A.U.S.E. spectacle lens 2P.A.U.S.E. spectacle lens 2 | Device | Assigned Intervention 3 |
Primary outcome
Axial Length
Time frame: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Stage 1: Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months), then 6- and 12-months after Stage 2: Dispensing Visit.
Difference in change from Stage 1 dispensing in axial length between each test and control. The change in axial length from the Stage 2 dispensing.
3 secondary outcomes
Cycloplegic spherical equivalent autorefraction
Time frame: Stage 1: Baseline, then 6- and 12-months after Stage 1: Dispensing Visit (up to 40 days from Baseline). Stage 2: Stage 1: 12 months visit, then 6- and 12-months after after Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months visit).
Visual performance as measured by high contrast visual acuity at 6 m
Time frame: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Dispensing Visit Stage 2: Dispensing Visit (up to 40 days from Stage 2: 12 month), then 6- and 12-months after Dispensing Visit
Visual performance as measured by a non validated questionnaire based on a 1-10
Time frame: Stage 1: 1-, 6-, and 12-months after Dispensing Visit (up to 40 days from Baseline). Stage 2: 6- and 12-months after Dispensing Visit (up to 40 days from Stage 1: 12-months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Tilia, MOptom, PhD principal investigator
nthalmic Pty Lyd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single vision spectacle lens, P.A.U.S.E. spectacle lens 1 and P.A.U.S.E. spectacle lens 2 in people with Myopia and Myopia Progression, run by nthalmic Pty Ltd at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial Length (time frame: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Stage 1: Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months), then 6- and 12-months after Stage 2: Dispensing Visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.